🇺🇸 FOSLEVODOPA in United States

FDA authorised FOSLEVODOPA on 19 March 2026

Marketing authorisation

FDA — authorised 19 March 2026

  • Application: NDA216962
  • Marketing authorisation holder: ABBVIE
  • Indication: Labeling
  • Status: approved

The FDA approved FOSLEVODOPA, developed by AbbVie, for its approved indication on 19 March 2026. The application number for this approval is NDA216962. FOSLEVODOPA was granted marketing authorisation through the standard expedited pathway.

Read official source →

FOSLEVODOPA in other countries

Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.

Other Neuroscience approved in United States

Frequently asked questions

Is FOSLEVODOPA approved in United States?

Yes. FDA authorised it on 19 March 2026.

Who is the marketing authorisation holder for FOSLEVODOPA in United States?

ABBVIE holds the US marketing authorisation.